PMA P190019S002
- Device
- Ranger Paclitaxel-Coated PTA Balloon Catheter
- Applicant
- Boston Scientific Corporation
- PMA number
- P190019
- Supplement
- S002
- Product code
- ONU
- Decision date
- 2020-11-12
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Replacement of the current software with new software to collect and process manufacturing test data.
Current openFDA PMA Record#
- Device
- Ranger Paclitaxel-Coated PTA Balloon Catheter
- Applicant
- Boston Scientific Corporation
- PMA number
- P190019
- Supplement
- S002
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2020-11-12
- Decision code
- OK30
- Date received
- 2020-11-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of the current software with new software to collect and process manufacturing test data.